The Effect of Different Focus of Attention Instructions on Resistance Training and Its Transfer to Gait Parameters in Older Adults
Strength Training for Gait Rehabilitation in Older Adults: Insights From Neuroscience
1 other identifier
interventional
45
1 country
1
Brief Summary
The goal of this clinical trial is to investigate the effects of strength training with different focus of attention strategies on plantar flexor force and how this affects gait in apparently healthy older adults. The main questions it aims to answer are:
- Is there an acute effect of focus of attention on non-linear force variability and the subjacent neurophysiological mechanisms in apparently healthy young and older adults?
- Is there a training effect of focus of attention on non-linear force variability and does it transfer to non-linear gait variability as well as the respective subjacent neurophysiological mechanisms in apparently healthy older adults? Researchers will compare two different external focus strategies with an internal focus to see if non-linear variability increases and subjacent neurophysiological mechanisms are more automized with an external focus of attention compared to an internal focus. In the acute study young adults are assessed as the differences between focus conditions are thought to be in the same direction as for older adults but attenuated. Participants will carry out training and strength assessments of the calf muscles and walking on a treadmill.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2024
CompletedFirst Submitted
Initial submission to the registry
July 26, 2024
CompletedFirst Posted
Study publicly available on registry
August 6, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2026
CompletedSeptember 18, 2025
September 1, 2025
2.1 years
July 26, 2024
September 12, 2025
Conditions
Outcome Measures
Primary Outcomes (6)
Change from Baseline in Non-linear Force Variability after each Week during Intervention and 2 Weeks Follow-Up
The non-linear variability of the temporal structure of the force signal of a 50 seconds isometric task at 50% of the maximum voluntary isometric contraction is analyzed using sample entropy (SampEn), which indicates the probability that short sequences of data points are repeated throughout the signal length. Lower SampEn (towards 0) is the consequence of similar distances between repetitions of those sequences, which indicates a more regular force output. A higher SampEn value (towards infinity) results from large differences of distances between repetitions of sequences, which designates a more irregular, variable force output.
Baseline, Week1, Week2, Week3, Week4 and Follow-Up (Week6)
Change from Baseline in Non-linear Gait Variability after each Week during Intervention and 2 Weeks Follow-Up
The non-linear variability of the temporal structure of the gait signal from a 12 minutes gait trial is analyzed using sample entropy (SampEn), which indicates the probability that short sequences of data points are repeated throughout the signal length. Lower SampEn (towards 0) is the consequence of similar distances between repetitions of those sequences, which indicates a more regular gait output. A higher SampEn value (towards infinity) results from large differences of distances between repetitions of sequences, which designates a more irregular, variable gait output.
Baseline, Week1, Week2, Week3, Week4 and Follow-Up (Week6)
Change from Baseline in Cortico-Spinal Excitability after 2 Weeks, 4 Weeks of Intervention and 2 Weeks Follow-Up
The cortical measures are assessed with transcranial magnetic stimulation (TMS). A stimulator generates motor evoked potentials (MEP) in the active soleus muscle during a low-intensity plantarflexion. To assess cortico-spinal excitability single-pulse TMS is applied. For cortico-spinal excitability the mean of the MEP amplitude from 10 stimulations is calculated. The values will be presented in % normalized to the EMG maximum voluntary contraction.
Baseline, Week2, Week4 and Follow-Up (Week6)
Change from Baseline in Cortico-Spinal Inhibition after 2 Weeks, 4 Weeks of Intervention and 2 Weeks Follow-Up
The cortical measures are assessed with transcranial magnetic stimulation (TMS). A stimulator generates motor evoked potentials (MEP) in the active soleus muscle during a low-intensity plantarflexion. To assess cortico-spinal inhibition single-pulse TMS is applied. For cortico-spinal inhibition the mean of electromyographic silent periods from 10 stimulations is calculated. The values are presented in ms.
Baseline, Week2, Week4 and Follow-Up (Week6)
Change from Baseline in Intra-Cortical Inhibition after 2 Weeks, 4 Weeks of Intervention and 2 Weeks Follow-Up
The cortical measures are assessed with transcranial magnetic stimulation (TMS). A stimulator generates motor evoked potentials (MEP) in the active soleus muscle during a low-intensity plantarflexion. To assess intra-cortical inhibition paired-pulse TMS is applied. For intra-cortical inhibition the mean of the MEP amplitude from 10 stimulations is calculated. The values will be presented in % normalized to the cortico-spinal excitability.
Baseline, Week2, Week4 and Follow-Up (Week6)
Change from Baseline in Intra-Cortical Facilitation after 2 Weeks, 4 Weeks of Intervention and 2 Weeks Follow-Up
The cortical measures are assessed with transcranial magnetic stimulation (TMS). A stimulator generates motor evoked potentials (MEP) in the active soleus muscle during a low-intensity plantarflexion. To assess intra-cortical facilitation paired-pulse TMS is applied. For intra-cortical facilitation the mean of the MEP amplitude from 10 stimulations is calculated. The values will be presented in % normalized to the cortico-spinal excitability.
Baseline, Week2, Week4 and Follow-Up (Week6)
Secondary Outcomes (5)
Change from Baseline in Antagonist Co-Contraction Index after 2Weeks, 4 Weeks of Intervention and 2 Weeks Follow-Up
Baseline, Week2, Week4 and Follow-Up (Week6)
Change from Baseline in Linear Force Variability after each Week during Intervention and 2 Weeks Follow-Up
Baseline, Week1, Week2, Week3, Week4 and Follow-Up (Week6)
Change from Baseline in Linear Gait Variability after each Week during Intervention and 2 Weeks Follow-Up
Baseline, Week1, Week2, Week3, Week4 and Follow-Up (Week6)
Change from Baseline of Hip, Knee, Ankle Range of Motion during Gait after 2Weeks, 4 Weeks of Intervention and 2 Weeks Follow-Up
Baseline, Week2, Week4 and Follow-Up (Week6)
Change from Baseline of Minimum Toe Clearance during Gait after after 2Weeks, 4 Weeks of Intervention and 2 Weeks Follow-Up
Baseline, Week2, Week4 and Follow-Up (Week6)
Study Arms (3)
Internal Focus Condition
ACTIVE COMPARATORIn the internal focus condition the participant is instructed to realize seated calf raises by focusing on contracting the plantar-flexors. In clinical applications the internal focus is the most commonly used instruction. It is not possible to have a neutral focus condition, as participants always have to receive instructions and will always be focusing on something. Therefore, the internal focus condition is used as an active comparator.
Proprioceptive External Focus Condition
EXPERIMENTALIn the proprioceptive external focus condition the participant is instructed to realize seated calf raises by focusing on lifting the machine's bar.
Visual External Focus Condition
EXPERIMENTALIn the visual external focus condition the participant is instructed to realize seated calf raises by focusing on a line representing the displacement of the bar projected on a screen.
Interventions
A 4 weeks strength training program of seated calf raises with progressive overload is carried out. A supervisor applies force specific internal focus instruction in three sessions per week with at least 48h rest time. One session consists of 3 series until failure with 75%RM. Rest intervals between series are defined as 2 minutes.
A 4 weeks strength training program of seated calf raises with progressive overload is carried out. A supervisor applies force specific proprioceptive external focus instruction in three sessions per week with at least 48h rest time. One session consists of 3 series until failure with 75%RM. Rest intervals between series are defined as 2 minutes.
A 4 weeks strength training program of seated calf raises with progressive overload is carried out. A supervisor applies force specific visual external focus instruction in three sessions per week with at least 48h rest time. One session consists of 3 series until failure with 75%RM. Rest intervals between series are defined as 2 minutes.
Eligibility Criteria
You may qualify if:
- \- Signed informed consent
You may not qualify if:
- Severe cardiovascular or pulmonary disease
- Oncological disease
- Lower limb disabilities
- Neurological disorders
- Inability to walk unassisted for 12 continuous minutes
- Cognitive impairment
- Falls in the prior 12 months
- Orthopedic concerns, which might limit force production
- Metal implants
- Medicine that can trigger side effects with TMS
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Egas Moniz School of Health & Science
Monte de Caparica, Almada, 2829 - 511, Portugal
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 26, 2024
First Posted
August 6, 2024
Study Start
April 1, 2024
Primary Completion
April 30, 2026
Study Completion
April 30, 2026
Last Updated
September 18, 2025
Record last verified: 2025-09